I have one of my admin/interns cataloging everything for posts coming Monday.
I have had the opportunity to read what many of you have shared with me. One prolific commentor seems to be confused by everything I say. I will attempt to clear the air, if in fact this is the case for multiple readers.
It is often the case that I am able to multi-task many complex thoughts in a dozen directions at the same time. - When I quickly write these out, unless you really understand and are aware of the source material, I can seem to be ranting with discord and no goal. However, when I write for the purpose of being direct with a stated proof, I am quit capable of presenting cohesive, solid, and rational material. All I hope is that the reader be able to separate emotion from truth, not pick apart the minutia of details that might have a grammar or other non-essential error.
It is my strong belief, and will continue as such, that Galena under the leadership of Steve Kriegsman, his sit-in CEO Mark Ahn, the companies several dozen employees, and their hand-picked (created) 700 employee CRO has little to no chance of bringing this compound to market. I also have a gut feeling science, the wording of the protocol, and the handling of the trial are on a path to failure for concomitant as well as fully different issues that will in short time begin to see the light.
What I will show you is that GALE has a study in crisis. For years they stated 100 sites. In the last months they have added about 50, while substituting maybe as many as dozens more. This means they have no enrollment, no results, and no one at the Physician level of these sites willing to put their patients on the GALE protocol/neuvax.
Most of what I will show is crisis and bad decisions. This includes a protocol with endpoints they are likely to fail for possibly only study design reasons, but fail nonetheless.
I find it scary that a company is wooing investors, cross-promoting heavy stroking and press releases with the CRO (Contract Research Organization) running their blinded study, and by blinded, we must believe they are not sneaking peaks at data along the way. This is why you have a very "clinical" relationship with your CRO - to make sure there is no chance one might perceive a cozy relationship.
In most cases, if anyone believed this was truly a breakthrough Immuno Vaccine, you would have no funding problems at Ph3, you would not have allowed (or helped form) a 700 person CRO to manage what they claim to be a multi-billion dollar opportunity. Confidence in compound would have seen this trial transition to a rescue trial with a top-line CRO at the helm.
I will present multiple documents about this CRO, the inappropriate GALE/CRO relationship, and the simple fact the CRO states "they do not work outside Ph2, as they are aware they do not understand the space." They said this - not me - Their EVP, on multiple occasions. I actually feel bad with a heavy dose of disgust at all of the smoke screens surrounding a product so emotional to so many - including myself.
GALE has also sued they co-developer of NeuVax to silence his dissent - as recently as Nov. 13. Again, the reason for the lawsuit comes down to money. They actually are suing for more than $100K - and they list about 10 things hurting them in one way - And I will actually throw in a few quote for you here - DIRECTLY from the lawsuit.
THE IRONY AND DISGUST ARE OBVIOUS!
Galena essentially states again and again that the co-inventor has challenged the way they are presenting HIS Ph1/2 results in marketing used for secondary offerings and also for pumping campaigns where retail investors are using the distorted and misleading wording to go for the retail investors money to fund their research. Secondarily, and almost comically, Galena states that he says they are committing securities fraud in making these statements. This lawsuit aside, which seeks only to quash Ioannides publishing, has come very close to writing their own story/outcome in an attack on another individual.
Regarding Galena's need to obtain Retail Level Financing:
COMPLAINT #11 (GALE's Typo's and odd phrasing):
"Since it is still in a development stage, Galena is dependent on periodic financings to fund its drug development efforts. Galena's ability to financings upon favorable terms, in turn, is heavily dependent on the market price of its stock. In addition, Galena's goodwill is diminished by the Comments. The long-term damages caused by Ioannides' demonstrably false and libelous Comments is to be determined at trial and pursuant to expert testimony."
Please note the irony of this next complaint from the second section of the lawsuit complaints:
"Among other things, such Comments falsely indicated and conveyed to the reader that Galena and its officers and directors are committing securities fraud..."
"More Galena complaints as to the harm they have been subjected, and thus, how they will not be able to raise funds through future offerings as no one will like them. As a result of the Ioannides' publication of the Comments, Galena has
been injured in its profession, trade and/or business because potential strategic partners or other third parties and investors are less interested in collaborating with or otherwise investing in Galena."
"Since Galena is a development - stage company, it is reliant upon the capital markets for the funding necessary to pursue its business plan, which includes seeking to commercialize its main product candidate, NeuVax,™ and Ioannides has severally damaged Galena in this respect."
Read for yourself the entire federal lawsuit:
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: Feel terrible for the thousands of retail investors who have done their DD, yet have no control over the exhaustive methods GALE has taken to be misinterpreted, to mislead, and to practice what seems to be a campaign to lie and sue anyone who brings their odd behavior to light.